D6970C00002: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Participants

Cardiology
Ekamol Tantisattamo
D6970C00002: A randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat on the Reduction of Systolic Blood Pressure in Participants with Uncontrolled Hypertension on Two or More Medications including Participants with Resistant Hypertension
Heart - Cardiovascular Circulatory

Study Description

Eligibility

Inclusion Criteria:

-Male or female participants must be ≥ 18 years old

-Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening

Fulfil at least 1 of the following 2 criteria:

  • uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
  • rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
  • Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
  • Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening

Randomisation Criterion:

  • Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit
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